Mens Minoxidil Hair Regrowth System

Mens Minoxidil Hair Regrowth System
SPL v4
SPL
SPL Set ID 80f91ed8-4f29-4a16-b2e5-fd74a11b6a61
Route
TOPICAL
Published
Effective Date 2024-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (50 mg)
Inactive Ingredients
Alcohol Propylene Glycol Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2023-06-16

Description

Drug Facts

Purpose

Hair regrowth treatment for men


Medication Information

Purpose

Hair regrowth treatment for men

Description

Drug Facts

Use

to regrow hair on the scalp (vertex only, see picture on side of carton)

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50569-3

Ask a doctor before use if you have heart disease

Section 53414-9

May be harmful if used when pregnant or breast-feeding.

Warnings

For external use only. For use by men only.

Directions
  • apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area
  • using more or more often will not improve results
  • continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again
Do Not Use If
  • you are a woman
  • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical solution is not intended for frontal baldness or receding hairline
  • you have no family history of hair loss
  • your hair loss is sudden and/or patchy
  • you do not know the reason for your hair loss
  • you are under 18 years of age. Do not use on babies and children
  • your scalp is red, inflamed, irritated or painful
  • you use other medicines on the scalp
Active Ingredient

Minoxidil 5% w/v

Other Information
  • see hair loss pictures on opposite side
  • before use, read all information on carton and enclosed leaflet
  • keep the insert. It contains important information.
  • hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men
  • in clinical studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution
  • store at controlled room temperature 20º to 25ºC (68º to 77ºF).
Inactive Ingredients

Alcohol, Propylene Glycol, Purified Water

When Using This Product
  • do not apply on other parts of the body
  • avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water
  • some people have experienced changes in hair color and/or texture
  • it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results.
  • the amount of hair regrowth is different for each person. This product will not work for all men.
Stop Use and Ask A Doctor If
  • chest pain, rapid heartbeat, faintness, or dizziness occurs
  • sudden, unexplained weight gain occurs
  • your hands or feet swell
  • scalp irritation or redness occurs
  • unwanted facial hair growth occurs

you do not see hair regrowth in 4 months

Principal Display Panel Kit Carton

MINOXIDIL

HAIR REGROWTH SYSTEM

CLINICALLY PROVEN TO HELP REGROW HAIR

KIT CONTENTS: STRENGTHENING SHAMPOO, REJUVENATING CONDITIONER,

MINOXIDIL TOPICAL SOLUTION USP (2 MONTH SUPPLY)

Principal Display Panel 2 60 Ml Bottle Dropcard

MEN'S

MINOXIDIL

HAIR REGROWTH SYSTEM

5% MINOXODIL TOPICAL SOLUTION, USP

Reactivates hair follicles to

stimulate regrowth

Clinically proven to help regrow hair

Topical Solution

Unscented

Minoxidil Topical Solution 5% is for men who have

a general thinning of hair on the top of the scalp

(vertex only, as shown). Not intended for frontal baldness

or a receding hairline. Minoxidil Topical Solution 5%

has been shown to regrow hair in men with the following

degrees of thinning hair of hair loss

If men have more hair loss or hair loss in a place

different than shown above, Minoxidil Topical

Solution 5% may not work.

Two month supply

Two 60 ml (2 fl oz) bottles

Principal Display Panel 200 Ml Bottle Label Shampoo

COMPLIMENTS OF

TOPIX

PHARMACEUTICALS, INC

Strengthening

Basil Root

Shampoo

HAIR GROWTH SYSTEM

Clean | Volumize | Strengthen

Net 6.7 fl. oz. (200 ml)

Available

Custom Branded

800.445.2595

[email protected]

Principal Display Panel 200 Ml Bottle Label Conditioner

COMPLIMENTS OF

TOPIX

PHARMACEUTICALS, INC

Rejuvenating

Basil Root

Conditioner

HAIR GROWTH SYSTEM

Condition | Volumize | Rejuvenate

Net 6.7 fl. oz. (200 ml)

Available

Custom Branded

800.445.2595

[email protected]


Structured Label Content

Use

to regrow hair on the scalp (vertex only, see picture on side of carton)

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50569-3 (50569-3)

Ask a doctor before use if you have heart disease

Section 53414-9 (53414-9)

May be harmful if used when pregnant or breast-feeding.

Purpose

Hair regrowth treatment for men

Warnings

For external use only. For use by men only.

Directions
  • apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area
  • using more or more often will not improve results
  • continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again
Do Not Use If (Do not use if)
  • you are a woman
  • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical solution is not intended for frontal baldness or receding hairline
  • you have no family history of hair loss
  • your hair loss is sudden and/or patchy
  • you do not know the reason for your hair loss
  • you are under 18 years of age. Do not use on babies and children
  • your scalp is red, inflamed, irritated or painful
  • you use other medicines on the scalp
Active Ingredient (Active ingredient)

Minoxidil 5% w/v

Other Information (Other information)
  • see hair loss pictures on opposite side
  • before use, read all information on carton and enclosed leaflet
  • keep the insert. It contains important information.
  • hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men
  • in clinical studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution
  • store at controlled room temperature 20º to 25ºC (68º to 77ºF).
Inactive Ingredients (Inactive ingredients)

Alcohol, Propylene Glycol, Purified Water

When Using This Product (When using this product)
  • do not apply on other parts of the body
  • avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water
  • some people have experienced changes in hair color and/or texture
  • it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results.
  • the amount of hair regrowth is different for each person. This product will not work for all men.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • chest pain, rapid heartbeat, faintness, or dizziness occurs
  • sudden, unexplained weight gain occurs
  • your hands or feet swell
  • scalp irritation or redness occurs
  • unwanted facial hair growth occurs

you do not see hair regrowth in 4 months

Principal Display Panel Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

MINOXIDIL

HAIR REGROWTH SYSTEM

CLINICALLY PROVEN TO HELP REGROW HAIR

KIT CONTENTS: STRENGTHENING SHAMPOO, REJUVENATING CONDITIONER,

MINOXIDIL TOPICAL SOLUTION USP (2 MONTH SUPPLY)

Principal Display Panel 2 60 Ml Bottle Dropcard (PRINCIPAL DISPLAY PANEL - 2-60 ml Bottle Dropcard)

MEN'S

MINOXIDIL

HAIR REGROWTH SYSTEM

5% MINOXODIL TOPICAL SOLUTION, USP

Reactivates hair follicles to

stimulate regrowth

Clinically proven to help regrow hair

Topical Solution

Unscented

Minoxidil Topical Solution 5% is for men who have

a general thinning of hair on the top of the scalp

(vertex only, as shown). Not intended for frontal baldness

or a receding hairline. Minoxidil Topical Solution 5%

has been shown to regrow hair in men with the following

degrees of thinning hair of hair loss

If men have more hair loss or hair loss in a place

different than shown above, Minoxidil Topical

Solution 5% may not work.

Two month supply

Two 60 ml (2 fl oz) bottles

Principal Display Panel 200 Ml Bottle Label Shampoo (PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label-Shampoo)

COMPLIMENTS OF

TOPIX

PHARMACEUTICALS, INC

Strengthening

Basil Root

Shampoo

HAIR GROWTH SYSTEM

Clean | Volumize | Strengthen

Net 6.7 fl. oz. (200 ml)

Available

Custom Branded

800.445.2595

[email protected]

Principal Display Panel 200 Ml Bottle Label Conditioner (PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label-Conditioner)

COMPLIMENTS OF

TOPIX

PHARMACEUTICALS, INC

Rejuvenating

Basil Root

Conditioner

HAIR GROWTH SYSTEM

Condition | Volumize | Rejuvenate

Net 6.7 fl. oz. (200 ml)

Available

Custom Branded

800.445.2595

[email protected]


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